Data / Medical devices / United States / Kova International Inc
Kova International Inc: FDA-registered device maker in Garden Grove, CA, United States, 5 510(k) clearances
Kova International Inc is registered with the FDA (registration 3010152370) in Garden Grove, CA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 4, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010152370
- Address
- 7272 Chapman Ave Suite B, Garden Grove, CA, United States, 92841
- Owner or operator
- LGC Clinical Diagnostics (10043604)
- Roles
- Manufacturer
- First device listed
- March 4, 2013
- Registered through
- 2026
- Brand names listed
- KOVA Cap, KOVA System Pac II, KOVA System Super Pac 1000, KOVA System Value Pac 500, KOVA-poc Dip-Tube with Microscopics (6x 15mL), KOVA-poc Dropper Bottle Control Set (10x 5mL), KOVA-poc Dropper Bottle Control Set (2x 5mL), KOVA-poc Dropper Bottle Control Set (4x 25mL) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Crystal Violet For Histology | ICF | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Manufacturer | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 1994 | K942853 | KOVA LIQUA-TROL | JJW | Substantially Equivalent | Hycor Biomedical, Inc. | accessdata.fda.gov |
| January 26, 1993 | K926095 | REFRACTROL-SP | JJX | Substantially Equivalent | Medical Specialties, Inc. | accessdata.fda.gov |
| October 5, 1984 | K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | JJW | Substantially Equivalent | Icl Scientific | accessdata.fda.gov |
| April 14, 1981 | K810917 | KOVA TROL I HUMAN URINE (DRIED) | JJW | Substantially Equivalent | Icl Scientific | accessdata.fda.gov |
| May 3, 1978 | K780482 | KOVA TROL III | JJW | Substantially Equivalent | Icl Scientific | accessdata.fda.gov |
Compare with other makers
- All makers of Urinalysis Controls (Assayed And Unassayed)
- All makers of Crystal Violet For Histology
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Station, Pipetting And Diluting, For Clinical Use
- All makers of Slides, Microscope
Updated October 4, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.